Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date; Request for Comments, 20825-20829 [2017-09029]
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Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Rules and Regulations
(d) Subject
Air Transport Association (ATA) of
America Code 53, Fuselage.
(e) Unsafe Condition
This AD was prompted by a determination
that undetected web fatigue cracking caused
by oil canning may exist in the station 1440
aft pressure bulkhead web. We are issuing
this AD to detect and correct fatigue cracking
of the aft pressure bulkhead web, which
could grow in length and ultimately reduce
the structural integrity of the web and lead
to rapid decompression of the airplane.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
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(g) Repetitive Inspections and Related
Investigative and Corrective Actions
At the applicable time specified in
paragraph 1.E., ‘‘Compliance,’’ of Boeing 707
Alert Service Bulletin A3543, dated
September 15, 2016, except as required by
paragraph (h)(1) of this AD: Do all applicable
actions specified in paragraphs (g)(1), (g)(2),
and (g)(3) of this AD, in accordance with the
Accomplishment Instructions of Boeing 707
Alert Service Bulletin A3543, dated
September 15, 2016, except as required by
paragraph (h)(2) of this AD.
(1) Do a detailed inspection of the station
1440 aft pressure bulkhead web for any oil
canning. Repeat the inspection at the
applicable time specified in paragraph 1.E.,
‘‘Compliance,’’ of Boeing 707 Alert Service
Bulletin A3543, dated September 15, 2016.
(2) Do all applicable related investigative
actions, including detailed, eddy current, and
high frequency eddy current (HFEC)
inspections. Repeat the applicable
inspections thereafter at the applicable time
specified in paragraph 1.E., ‘‘Compliance,’’ of
Boeing 707 Alert Service Bulletin A3543,
dated September 15, 2016.
(3) Do all applicable corrective actions at
the applicable time specified in paragraph
1.E., ‘‘Compliance,’’ of Boeing 707 Alert
Service Bulletin A3543, dated September 15,
2016.
(h) Service Information Exceptions
(1) Where Boeing 707 Alert Service
Bulletin A3543, dated September 15, 2016,
specifies a compliance time ‘‘after the
original issue date of this service bulletin,’’
this AD requires compliance within the
specified compliance time after the effective
date of this AD.
(2) Where Boeing 707 Alert Service
Bulletin A3543, dated September 15, 2016,
specifies to contact Boeing for repair
instructions, and specifies that action as
Required for Compliance (RC), this AD
requires repair using a method approved in
accordance with the procedures specified in
paragraph (j) of this AD.
(i) Special Flight Permit
Special flight permits may be issued in
accordance with sections 21.197 and 21.199
of the Federal Aviation Regulations (14 CFR
21.197 and 21.199) to operate the airplane to
a location where the airplane can be repaired,
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but if any crack is found as identified in
Boeing 707 Alert Service Bulletin A3543,
dated September 15, 2016, concurrence by
the Manager, Los Angeles Aircraft
Certification Office (ACO), FAA, is required
before issuance of the special flight permit.
(j) Alternative Methods of Compliance
(AMOCs)
(1) The Manager, Los Angeles ACO, FAA,
has the authority to approve AMOCs for this
AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal
inspector or local Flight Standards District
Office, as appropriate. If sending information
directly to the manager of the ACO, send it
to the attention of the person identified in
paragraph (k) of this AD. Information may be
emailed to: 9-ANM-LAACO-AMOCRequests@faa.gov.
(2) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the local flight standards district office/
certificate holding district office.
(3) An AMOC that provides an acceptable
level of safety may be used for any repair,
modification, or alteration required by this
AD if it is approved by the Boeing
Commercial Airplanes Organization
Designation Authorization (ODA) that has
been authorized by the Manager, Los Angeles
ACO, to make those findings. To be
approved, the repair method, modification
deviation, or alteration deviation must meet
the certification basis of the airplane, and the
approval must specifically refer to this AD.
(4) Except as required by paragraph (h) of
this AD: For service information that
contains steps that are labeled as RC, the
provisions of paragraphs (j)(4)(i) and (j)(4)(ii)
of this AD apply.
(i) The steps labeled as RC, including
substeps under an RC step and any figures
identified in an RC step, must be done to
comply with the AD. If a step or substep is
labeled ‘‘RC Exempt,’’ then the RC
requirement is removed from that step or
substep. An AMOC is required for any
deviations to RC steps, including substeps
and identified figures.
(ii) Steps not labeled as RC may be
deviated from using accepted methods in
accordance with the operator’s maintenance
or inspection program without obtaining
approval of an AMOC, provided the RC steps,
including substeps and identified figures, can
still be done as specified, and the airplane
can be put back in an airworthy condition.
(k) Related Information
For more information about this AD,
contact George Garrido, Aerospace Engineer,
Airframe Branch, ANM–120L, FAA, Los
Angeles Aircraft Certification Office (ACO),
3960 Paramount Boulevard, Lakewood, CA
90712–4137; phone: 562–627–5232; fax: 562–
627–5210; email: george.garrido@faa.gov.
(l) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
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20825
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
(i) Boeing 707 Alert Service Bulletin
A3543, dated September 15, 2016.
(ii) Reserved.
(3) For service information identified in
this AD, contact Boeing Commercial
Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd.,
MC 110–SK57, Seal Beach, CA 90740–5600;
telephone 562–797–1717; Internet https://
www.myboeingfleet.com.
(4) You may view this service information
at the FAA, Transport Airplane Directorate,
1601 Lind Avenue SW., Renton, WA. For
information on the availability of this
material at the FAA, call 425–227–1221.
(5) You may view this service information
that is incorporated by reference at the
National Archives and Records
Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Renton, Washington, on April 24,
2017.
Paul Bernado,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 2017–08828 Filed 5–3–17; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 11 and 101
[Docket No. FDA–2011–F–0172]
RIN 0910–ZA48
Food Labeling; Nutrition Labeling of
Standard Menu Items in Restaurants
and Similar Retail Food
Establishments; Extension of
Compliance Date; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Interim final rule; extension of
compliance date; request for comments.
ACTION:
The Food and Drug
Administration (FDA or we) is
extending the compliance date for the
final rule requiring disclosure of certain
nutrition information for standard menu
items in certain restaurants and retail
food establishments. In the Federal
Register of December 30, 2016, we
stated that the compliance date for the
final rule would be May 5, 2017. We are
extending the compliance date to May 7,
2018. We are taking this action to enable
us to consider how we might further
reduce the regulatory burden or increase
SUMMARY:
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Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Rules and Regulations
Written/Paper Submissions
flexibility while continuing to achieve
our regulatory objectives, in keeping
with the Administration’s policies.
Compliance date: As of May 4,
2017, the compliance date for covered
establishments set out in the final rule
published December 1, 2014 (79 FR
71156), and extended in final rules
published on July 10, 2015 (80 FR
39675) and December 30, 2016 (81 FR
96364), is further extended. Covered
establishments must comply with the
rule published December 1, 2014 (79 FR
71156), by May 7, 2018.
Comment date: Submit either
electronic or written comments
regarding this compliance date
extension, implementation of the
December 2014 final rule, and the
various topics flagged in the
SUPPLEMENTARY INFORMATION section of
this document, by July 3, 2017.
DATES:
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of July
3, 2017. Comments received by mail/
hand delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
ADDRESSES:
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Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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13:02 May 03, 2017
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Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2011–F–0172 for ‘‘Food Labeling;
Nutrition Labeling of Standard Menu
Items in Restaurants and Similar Retail
Food Establishments; Extension of
Compliance Date; Request for
Comments.’’ Received comments, those
filed in a timely manner (see DATES),
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
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fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Felicia B. Billingslea, Center for Food
Safety and Applied Nutrition (HFS–
820), Food and Drug Administration,
5001 Campus Dr., College Park, MD
20740, 240–402–2371.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 1,
2014 (79 FR 71156), we published a
final rule requiring disclosure of certain
nutrition information for standard menu
items in certain restaurants and retail
food establishments. The final rule,
which is now codified at § 101.11 (21
CFR 101.11), implements provisions of
section 403(q)(5)(H) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
343(q)(5)(H)) and:
• Defines terms, including terms that
describe criteria for determining
whether an establishment is subject to
the rule;
• establishes which foods are subject
to the nutrition labeling requirements
and which foods are not subject to these
requirements;
• requires that calories for standard
menu items be declared on menus and
menu boards that list such foods for
sale;
• requires that calories for standard
menu items that are self-service or on
display be declared on signs adjacent to
such foods;
• requires that written nutrition
information for standard menu items be
available to consumers who ask to see
it;
• requires, on menus and menu
boards, a succinct statement concerning
suggested daily caloric intake (succinct
statement), designed to help the public
understand the significance of the
calorie declarations;
• requires, on menus and menu
boards, a statement regarding the
availability of the written nutrition
information (statement of availability);
• establishes requirements for
determination of nutrient content of
standard menu items;
• establishes requirements for
substantiation of nutrient content
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determined for standard menu items,
including requirements for records that
a covered establishment must make
available to FDA within a reasonable
period of time upon request; and
• establishes terms and conditions
under which restaurants and similar
retail food establishments not otherwise
subject to the rule could elect to be
subject to the requirements by
registering with FDA.
In the preamble to the final rule (79
FR 71156 at 71239 through 71241), we
stated that the rule would be effective
on December 1, 2015, and also provided
a compliance date of December 1, 2015,
for covered establishments. The final
rule (at § 101.11(a)) defines ‘‘covered
establishment’’ as a restaurant or similar
retail food establishment that is a part
of a chain with 20 or more locations
doing business under the same name
(regardless of the type of ownership,
e.g., individual franchises) and offering
for sale substantially the same menu
items, as well as a restaurant or similar
retail food establishment that is
voluntarily registered to be covered
under § 101.11(d).
II. Extension of the Compliance Date
and Request for Comments
In the Federal Register of July 10,
2015 (80 FR 39675), in response to
requests from affected entities, we
announced our decision to extend the
compliance date for the final rule to
December 1, 2016.
On December 18, 2015, the President
signed the Consolidated Appropriations
Act, 2016 (Pub. L. 114–113). Section 747
of that law states that none of the funds
made available under the Consolidated
Appropriations Act may be used to
implement, administer, or enforce the
final rule entitled ‘‘Food Labeling;
Nutrition Labeling of Standard Menu
Items in Restaurants and Similar Retail
Food Establishments’’ until the later of
December 1, 2016 or 1 year after the
date we publish a Level 1 guidance with
respect to nutrition labeling of standard
menu items in restaurants and similar
retail food establishments.
In the Federal Register of May 5, 2016
(81 FR 27067), we announced the
availability of the Level 1 guidance
document and stated that enforcement
of the final rule published December 1,
2014, would commence on May 5, 2017
(81 FR 27067 at 27068). In the Federal
Register of December 30, 2016 (81 FR
96364), we confirmed that the
compliance date would be May 5, 2017.
This interim final rule extends the
compliance date to May 7, 2018. We are
taking this action consistent with
Executive Orders 13777, 13771, and
13563, as well as in response to the
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diverse and complex set of stakeholders
affected by the rule and continued,
numerous, and fundamental questions
they raise regarding the final rule and its
implementation. The continued,
fundamental questions and concerns
with the final rule suggest that critical
implementation issues, including some
related to scope, may not have been
fully understood and the agency does
not want to proceed if we do not have
all of the relevant facts on these matters.
Retailers with many different and
diverse business models have raised
concerns about how the rule lacks
flexibility to permit them to provide
meaningful nutrition information to
consumers given their type of business
and different operations. Moreover, we
continue to receive many questions
about calorie disclosure signage for selfservice foods, including buffets and
grab-and-go foods. We do not want to
proceed with a rule that might turn out
to be too inflexible to support
innovation in delivering information to
consumers. In addition, we have
received questions regarding how to
distinguish a menu, which requires the
posting of calorie information, from
advertisements and other marketing
pieces, which do not require calorie
information. Many of these menu
questions are complex and have
highlighted for the agency the need for
further consideration and clarification.
How to address the natural calorie
variations for foods has also been raised
by stakeholders as an issue that needs
additional guidance and clarity. Finally,
some entities with certain business
models have stated that they continue to
have questions about what provisions of
the final rule are applicable to them. We
believe questions like this still need to
be addressed.
The previous extensions, as well as
Congressional concern regarding
implementation expressed through
letters and appropriations law, are a
reflection of the challenge in
implementing this rule for a diverse
industry of approximately 298,600
covered establishments, organized
under 2,130 chains, that we estimated to
be covered by the 2014 final rule.
Executive Order 13777, ‘‘Enforcing the
Regulatory Reform Agenda’’ (82 FR
12285, March 1, 2017), sets forth a
policy to alleviate unnecessary
regulatory burdens. Given the principles
and policies set forth in these executive
orders, particularly with respect to
reducing burdens, reducing costs,
maintaining flexibility, and improving
effectiveness, we have decided to
extend the compliance date to May 7,
2018. The additional time will allow us
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20827
to consider what opportunities there
may be to address these fundamental
and complex questions and reduce the
cost and enhance the flexibility of these
requirements beyond those reflected in
the final rule. Given our decision to
reconsider the rule consistent with these
Executive Orders, it would not make
sense to require establishments covered
by our final rule to come into
compliance with the rule (for which
compliance is not yet required), as well
as incur additional ongoing costs to
maintain or update compliance, when
these requirements may change as a
result of our reconsideration of the rule.
We solicit comment on the extension of
the compliance date.
To assist us in our review, we invite
interested parties to submit comments
on how we might further reduce the
regulatory burden or increase flexibility
while continuing to achieve our
regulatory objectives to provide
consumers with nutrition information
so that they can make informed choices
for themselves and their families. In
particular, and in light of the issues we
have noted above, we are interested in
hearing about approaches to reduce the
regulatory burden or increase flexibility
with respect to:
(1) Calorie disclosure signage for selfservice foods, including buffets and
grab-and-go foods;
(2) methods for providing calorie
disclosure information other than on the
menu itself, including how different
kinds of retailers might use different
methods; and
(3) criteria for distinguishing between
menus and other information presented
to the consumer. (See ADDRESSES for
instructions on submitting comments.)
These questions have been identified by
stakeholders as among the fundamental
issues that continue to pose significant
implementation challenges. As of April
7, 2017, we have received five requests
for an extension of the compliance
period, which we will add to the docket.
In addition, on April 5, 2017, a request
to stay the effective date was submitted
to FDA (see Docket No. FDA–2017–P–
2164); this request is currently under
consideration.
To the extent that 5 U.S.C. 553 applies
to this extension of the compliance date,
the action is exempt from notice and
comment because it constitutes a rule of
procedure under 5 U.S.C. 553(b)(A).
Alternatively, to the extent that the
notice-and-comment and delayed
effective date requirements set forth in
5 U.S.C. 553 applies to this action, the
implementation of this action without
opportunity for public comment,
effective immediately upon publication
today in the Federal Register, is based
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on the good cause exceptions in 5 U.S.C.
553(b)(B) and (d)(3). Given the
imminence of the compliance date (May
5, 2017), and the fact that, as discussed
above, a number of regulated
establishments continue to raise
numerous, complex questions about
applicability of the menu labeling
requirements and about how to
implement them, we have decided that
providing an opportunity for public
comment would be impracticable and
contrary to the public interest. This is
because providing immediate notice to
covered establishments of the additional
time to come into compliance allows for
more efficient planning and accounting
for implementation of requirements,
thus reducing regulatory burden and
costs on affected entities. In addition,
providing immediate notice that there
will be additional time to comply is
necessary so that affected entities can
avoid incurring immediate costs and
efficiently plan and account for
implementation of the requirements by
the imminent compliance date. Good
cause exists to delay the compliance
date without comment and effective
immediately. In accordance with 21
CFR 10.40(e)(1), however, we note that
interested parties may provide comment
on the compliance date extension,
including whether it should be modified
or revoked. In addition, interested
parties may submit comments on how
we might further reduce the regulatory
burden or increase flexibility while
continuing to achieve our regulatory
objectives with respect to providing
consumers with nutrition information
so that they can make informed choices
for themselves and their families. In
addition, as we have done throughout
this complex rulemaking process, we
will continue to work with stakeholders
as we go forward.
III. Economic Analysis of Impacts
We have examined the impacts of the
interim final rule under Executive Order
12866, Executive Order 13563,
Executive Order 13771, the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4). Executive Orders
12866 and 13563 direct us to assess all
costs and benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety,
and other advantages; distributive
impacts; and equity). Executive Order
13771 requires that the costs associated
with new regulations shall ‘‘be offset by
the elimination of existing costs
associated with at least two prior
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regulations.’’ We have developed an
Economic Analysis of Impacts that
assesses the impacts of the interim final
rule, including cost savings to industry
and foregone benefits to consumers. We
estimate at least one type of impact in
at least one year to be greater than $100
million. Thus, we believe that this
interim final rule is an economically
significant regulatory action as defined
by Executive Order 12866.
The Regulatory Flexibility Act
requires Agencies to analyze regulatory
options that would minimize any
significant impact of a rule on small
entities. Because this rule reduces the
burden on covered establishments by
further extending the compliance date
for the ‘‘Food Labeling: Nutrition
Labeling of Standard Menu Items in
Restaurants and Similar Retail Food
Establishments’’ final rule (79 FR 71156,
December 1, 2014 (final rule); 80 FR
39675, July 10, 2015 (extending the
compliance date to December 1, 2016);
81 FR 96364, December 30, 2016
(clarifying extension of the compliance
date to May 5, 2017)), we certify the
interim final rule will not have a
significant economic impact on a
substantial number of small entities.
The Unfunded Mandates Reform Act
of 1995 (section 202(a)) requires us to
prepare a written statement, which
includes an assessment of anticipated
costs and benefits, before issuing ‘‘any
rule that includes any Federal mandate
that may result in the expenditure by
State, local, and tribal governments, in
the aggregate, or by the private sector, of
$100,000,000 or more (adjusted
annually for inflation) in any one year.’’
The current threshold after adjustment
for inflation is $148 million, using the
most current (2016) Implicit Price
Deflator for the Gross Domestic Product.
This interim final rule would not result
in an expenditure by industry in any
year that meets or exceeds this amount.
This interim final rule extends the
compliance date to May 7, 2018, for the
final rule requiring disclosure of certain
nutrition information for standard menu
items in certain restaurants and similar
retail food establishments. The principal
benefit of this interim final rule will be
the reduction in costs to covered
establishments associated with
extending the compliance date by one
year. The total annualized benefit (i.e.,
cost savings) of this interim final rule,
using a 3-percent discount rate over 20
years, would be from $2 to $6 million;
with a 7-percent discount rate, the
annualized benefit would be $3 to $8
million. The principal cost of this
interim final rule will be the reduction
in benefits to consumers associated with
extending the compliance date by one
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year. The total annualized cost (i.e.,
foregone benefits) of this interim final
rule, using a 3-percent discount rate
over 20 years, would be from $5 to $15
million; with a 7-percent discount rate,
the annualized cost would be $6 to $19
million. Extending the compliance date
of the ‘‘Food Labeling: Nutrition
Labeling of Standard Menu Items in
Restaurants and Similar Retail Food
Establishments’’ final rule by one year
reduces the annualized net benefits
(discounted at 3 percent) approximately
1 percent, from $506 million to $501
million. While average annualized net
benefits decrease by $5 million, they are
still positive. We recognize that there
may be additional costs and benefits to
both consumers and covered
establishments that we do not have the
data to quantify here. We are presenting
the estimated benefits and costs of the
menu labeling final rule, which takes
effect according to the dates in this
interim final rule. These quantitative
estimates reflect an assumed baseline in
which the menu labeling regulation
eventually goes fully into effect. If
statutory or other changes that are
separate from FDA rulemaking were to
impact full implementation, the
quantitative benefits estimates would be
lower and the quantitative cost
estimates higher than shown here. We
invite comment on both this Regulatory
Impact Analysis and the Regulatory
Impact Analysis for the December 2014
final rule.
The full analysis of economic impacts
is available in the docket for this interim
final rule (Ref. 1) and at https://
www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/
EconomicAnalyses/default.htm.
IV. Paperwork Reduction Act
This interim final rule contains no
collection of information. Therefore,
clearance by the Office of Management
and Budget under the Paperwork
Reduction Act of 1995 is not required.
V. Analysis of Environmental Impact
We have determined under 21 CFR
25.30(k) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
VI. Reference
The following reference is on display
in the Division of Dockets Management
(see ADDRESSES) and is available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; it is also available electronically
E:\FR\FM\04MYR1.SGM
04MYR1
Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Rules and Regulations
at https://www.regulations.gov. FDA has
verified the Web site addresses, as of the
date this document publishes in the
Federal Register, but Web sites are
subject to change over time.
1. FDA, interim economic impact analysis for
‘‘Food Labeling; Nutrition Labeling of
Standard Menu Items in Restaurants and
Similar Retail Food Establishments;
Extension of Compliance Date; Request
for Comment,’’ April 2017. Available at:
https://www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/
EconomicAnalyses.
Dated: May 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–09029 Filed 5–1–17; 4:15 pm]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 177
[Docket No. FDA–2016–F–1805]
Indirect Food Additives: Polymers
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or we) is
amending the food additive regulations
to no longer provide for the use of
potassium perchlorate as an additive in
closure-sealing gaskets for food
containers because this use has been
abandoned. This action is in response to
a petition filed by Keller and Heckman
LLP on behalf of the Society of the
Plastics Industry, Inc.
DATES: This rule is effective May 4,
2017. Submit either electronic or
written objections and requests for a
hearing on the final rule by June 5,
2017. See the ADDRESSES section, and
SUPPLEMENTARY INFORMATION section VIII
of this document, for further
information on the filing of objections.
ADDRESSES: You may submit objections
and requests for a hearing as follows.
Please note that late, untimely filed
objections will not be considered.
Electronic objections must be submitted
on or before June 5, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
June 5, 2017. Objections received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
pmangrum on DSK3GDR082PROD with RULES
SUMMARY:
VerDate Sep<11>2014
13:02 May 03, 2017
Jkt 241001
delivery service acceptance receipt is on
or before that date.
Electronic Submissions
Submit electronic objections in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Objections submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
objection will be made public, you are
solely responsible for ensuring that your
objection does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
objection, that information will be
posted on https://www.regulations.gov.
• If you want to submit an objection
with confidential information that you
do not wish to be made available to the
public, submit the objection as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper objections
submitted to the Division of Dockets
Management, FDA will post your
objection, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–F–1805 for ‘‘Indirect Food
Additives: Polymers.’’ Received
objections, those filed in a timely
manner (see DATES), will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit an objection with confidential
information that you do not wish to be
made publicly available, submit your
objections only as a written/paper
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
20829
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ We
will review this copy, including the
claimed confidential information, in our
consideration of comments. The second
copy, which will have the claimed
confidential information redacted/
blacked out, will be available for public
viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Vivian Gilliam, Center for Food Safety
and Applied Nutrition (HFS–275), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740–3835, 240–
402–1193.
SUPPLEMENTARY INFORMATION:
I. Background
In a document published in the
Federal Register of June 30, 2016 (81 FR
42585), we announced that we filed a
food additive petition (FAP 6B4816)
submitted on behalf of Society of the
Plastics Industry, Inc. (SPI) by Keller
and Heckman LLP, 1001 G Street NW.,
Suite 500 West, Washington, DC 20001.
The petition proposed to amend
§ 177.1210 (21 CFR 177.1210) to no
longer provide for the use of potassium
perchlorate as an additive in closuresealing gaskets for food containers
because the use has been intentionally
and permanently abandoned.
E:\FR\FM\04MYR1.SGM
04MYR1
Agencies
[Federal Register Volume 82, Number 85 (Thursday, May 4, 2017)]
[Rules and Regulations]
[Pages 20825-20829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-09029]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 11 and 101
[Docket No. FDA-2011-F-0172]
RIN 0910-ZA48
Food Labeling; Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments; Extension of
Compliance Date; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim final rule; extension of compliance date; request for
comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is extending the
compliance date for the final rule requiring disclosure of certain
nutrition information for standard menu items in certain restaurants
and retail food establishments. In the Federal Register of December 30,
2016, we stated that the compliance date for the final rule would be
May 5, 2017. We are extending the compliance date to May 7, 2018. We
are taking this action to enable us to consider how we might further
reduce the regulatory burden or increase
[[Page 20826]]
flexibility while continuing to achieve our regulatory objectives, in
keeping with the Administration's policies.
DATES: Compliance date: As of May 4, 2017, the compliance date for
covered establishments set out in the final rule published December 1,
2014 (79 FR 71156), and extended in final rules published on July 10,
2015 (80 FR 39675) and December 30, 2016 (81 FR 96364), is further
extended. Covered establishments must comply with the rule published
December 1, 2014 (79 FR 71156), by May 7, 2018.
Comment date: Submit either electronic or written comments
regarding this compliance date extension, implementation of the
December 2014 final rule, and the various topics flagged in the
SUPPLEMENTARY INFORMATION section of this document, by July 3, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of July 3, 2017. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2011-F-0172 for ``Food Labeling; Nutrition Labeling of Standard
Menu Items in Restaurants and Similar Retail Food Establishments;
Extension of Compliance Date; Request for Comments.'' Received
comments, those filed in a timely manner (see DATES), will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Division of Dockets Management. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, Center for
Food Safety and Applied Nutrition (HFS-820), Food and Drug
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 1, 2014 (79 FR 71156), we
published a final rule requiring disclosure of certain nutrition
information for standard menu items in certain restaurants and retail
food establishments. The final rule, which is now codified at Sec.
101.11 (21 CFR 101.11), implements provisions of section 403(q)(5)(H)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(H))
and:
Defines terms, including terms that describe criteria for
determining whether an establishment is subject to the rule;
establishes which foods are subject to the nutrition
labeling requirements and which foods are not subject to these
requirements;
requires that calories for standard menu items be declared
on menus and menu boards that list such foods for sale;
requires that calories for standard menu items that are
self-service or on display be declared on signs adjacent to such foods;
requires that written nutrition information for standard
menu items be available to consumers who ask to see it;
requires, on menus and menu boards, a succinct statement
concerning suggested daily caloric intake (succinct statement),
designed to help the public understand the significance of the calorie
declarations;
requires, on menus and menu boards, a statement regarding
the availability of the written nutrition information (statement of
availability);
establishes requirements for determination of nutrient
content of standard menu items;
establishes requirements for substantiation of nutrient
content
[[Page 20827]]
determined for standard menu items, including requirements for records
that a covered establishment must make available to FDA within a
reasonable period of time upon request; and
establishes terms and conditions under which restaurants
and similar retail food establishments not otherwise subject to the
rule could elect to be subject to the requirements by registering with
FDA.
In the preamble to the final rule (79 FR 71156 at 71239 through
71241), we stated that the rule would be effective on December 1, 2015,
and also provided a compliance date of December 1, 2015, for covered
establishments. The final rule (at Sec. 101.11(a)) defines ``covered
establishment'' as a restaurant or similar retail food establishment
that is a part of a chain with 20 or more locations doing business
under the same name (regardless of the type of ownership, e.g.,
individual franchises) and offering for sale substantially the same
menu items, as well as a restaurant or similar retail food
establishment that is voluntarily registered to be covered under Sec.
101.11(d).
II. Extension of the Compliance Date and Request for Comments
In the Federal Register of July 10, 2015 (80 FR 39675), in response
to requests from affected entities, we announced our decision to extend
the compliance date for the final rule to December 1, 2016.
On December 18, 2015, the President signed the Consolidated
Appropriations Act, 2016 (Pub. L. 114-113). Section 747 of that law
states that none of the funds made available under the Consolidated
Appropriations Act may be used to implement, administer, or enforce the
final rule entitled ``Food Labeling; Nutrition Labeling of Standard
Menu Items in Restaurants and Similar Retail Food Establishments''
until the later of December 1, 2016 or 1 year after the date we publish
a Level 1 guidance with respect to nutrition labeling of standard menu
items in restaurants and similar retail food establishments.
In the Federal Register of May 5, 2016 (81 FR 27067), we announced
the availability of the Level 1 guidance document and stated that
enforcement of the final rule published December 1, 2014, would
commence on May 5, 2017 (81 FR 27067 at 27068). In the Federal Register
of December 30, 2016 (81 FR 96364), we confirmed that the compliance
date would be May 5, 2017.
This interim final rule extends the compliance date to May 7, 2018.
We are taking this action consistent with Executive Orders 13777,
13771, and 13563, as well as in response to the diverse and complex set
of stakeholders affected by the rule and continued, numerous, and
fundamental questions they raise regarding the final rule and its
implementation. The continued, fundamental questions and concerns with
the final rule suggest that critical implementation issues, including
some related to scope, may not have been fully understood and the
agency does not want to proceed if we do not have all of the relevant
facts on these matters. Retailers with many different and diverse
business models have raised concerns about how the rule lacks
flexibility to permit them to provide meaningful nutrition information
to consumers given their type of business and different operations.
Moreover, we continue to receive many questions about calorie
disclosure signage for self-service foods, including buffets and grab-
and-go foods. We do not want to proceed with a rule that might turn out
to be too inflexible to support innovation in delivering information to
consumers. In addition, we have received questions regarding how to
distinguish a menu, which requires the posting of calorie information,
from advertisements and other marketing pieces, which do not require
calorie information. Many of these menu questions are complex and have
highlighted for the agency the need for further consideration and
clarification. How to address the natural calorie variations for foods
has also been raised by stakeholders as an issue that needs additional
guidance and clarity. Finally, some entities with certain business
models have stated that they continue to have questions about what
provisions of the final rule are applicable to them. We believe
questions like this still need to be addressed.
The previous extensions, as well as Congressional concern regarding
implementation expressed through letters and appropriations law, are a
reflection of the challenge in implementing this rule for a diverse
industry of approximately 298,600 covered establishments, organized
under 2,130 chains, that we estimated to be covered by the 2014 final
rule. Executive Order 13777, ``Enforcing the Regulatory Reform Agenda''
(82 FR 12285, March 1, 2017), sets forth a policy to alleviate
unnecessary regulatory burdens. Given the principles and policies set
forth in these executive orders, particularly with respect to reducing
burdens, reducing costs, maintaining flexibility, and improving
effectiveness, we have decided to extend the compliance date to May 7,
2018. The additional time will allow us to consider what opportunities
there may be to address these fundamental and complex questions and
reduce the cost and enhance the flexibility of these requirements
beyond those reflected in the final rule. Given our decision to
reconsider the rule consistent with these Executive Orders, it would
not make sense to require establishments covered by our final rule to
come into compliance with the rule (for which compliance is not yet
required), as well as incur additional ongoing costs to maintain or
update compliance, when these requirements may change as a result of
our reconsideration of the rule. We solicit comment on the extension of
the compliance date.
To assist us in our review, we invite interested parties to submit
comments on how we might further reduce the regulatory burden or
increase flexibility while continuing to achieve our regulatory
objectives to provide consumers with nutrition information so that they
can make informed choices for themselves and their families. In
particular, and in light of the issues we have noted above, we are
interested in hearing about approaches to reduce the regulatory burden
or increase flexibility with respect to:
(1) Calorie disclosure signage for self-service foods, including
buffets and grab-and-go foods;
(2) methods for providing calorie disclosure information other than
on the menu itself, including how different kinds of retailers might
use different methods; and
(3) criteria for distinguishing between menus and other information
presented to the consumer. (See ADDRESSES for instructions on
submitting comments.) These questions have been identified by
stakeholders as among the fundamental issues that continue to pose
significant implementation challenges. As of April 7, 2017, we have
received five requests for an extension of the compliance period, which
we will add to the docket. In addition, on April 5, 2017, a request to
stay the effective date was submitted to FDA (see Docket No. FDA-2017-
P-2164); this request is currently under consideration.
To the extent that 5 U.S.C. 553 applies to this extension of the
compliance date, the action is exempt from notice and comment because
it constitutes a rule of procedure under 5 U.S.C. 553(b)(A).
Alternatively, to the extent that the notice-and-comment and delayed
effective date requirements set forth in 5 U.S.C. 553 applies to this
action, the implementation of this action without opportunity for
public comment, effective immediately upon publication today in the
Federal Register, is based
[[Page 20828]]
on the good cause exceptions in 5 U.S.C. 553(b)(B) and (d)(3). Given
the imminence of the compliance date (May 5, 2017), and the fact that,
as discussed above, a number of regulated establishments continue to
raise numerous, complex questions about applicability of the menu
labeling requirements and about how to implement them, we have decided
that providing an opportunity for public comment would be impracticable
and contrary to the public interest. This is because providing
immediate notice to covered establishments of the additional time to
come into compliance allows for more efficient planning and accounting
for implementation of requirements, thus reducing regulatory burden and
costs on affected entities. In addition, providing immediate notice
that there will be additional time to comply is necessary so that
affected entities can avoid incurring immediate costs and efficiently
plan and account for implementation of the requirements by the imminent
compliance date. Good cause exists to delay the compliance date without
comment and effective immediately. In accordance with 21 CFR
10.40(e)(1), however, we note that interested parties may provide
comment on the compliance date extension, including whether it should
be modified or revoked. In addition, interested parties may submit
comments on how we might further reduce the regulatory burden or
increase flexibility while continuing to achieve our regulatory
objectives with respect to providing consumers with nutrition
information so that they can make informed choices for themselves and
their families. In addition, as we have done throughout this complex
rulemaking process, we will continue to work with stakeholders as we go
forward.
III. Economic Analysis of Impacts
We have examined the impacts of the interim final rule under
Executive Order 12866, Executive Order 13563, Executive Order 13771,
the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with new regulations shall ``be
offset by the elimination of existing costs associated with at least
two prior regulations.'' We have developed an Economic Analysis of
Impacts that assesses the impacts of the interim final rule, including
cost savings to industry and foregone benefits to consumers. We
estimate at least one type of impact in at least one year to be greater
than $100 million. Thus, we believe that this interim final rule is an
economically significant regulatory action as defined by Executive
Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this rule reduces the burden on covered
establishments by further extending the compliance date for the ``Food
Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and
Similar Retail Food Establishments'' final rule (79 FR 71156, December
1, 2014 (final rule); 80 FR 39675, July 10, 2015 (extending the
compliance date to December 1, 2016); 81 FR 96364, December 30, 2016
(clarifying extension of the compliance date to May 5, 2017)), we
certify the interim final rule will not have a significant economic
impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``any rule that includes
any Federal mandate that may result in the expenditure by State, local,
and tribal governments, in the aggregate, or by the private sector, of
$100,000,000 or more (adjusted annually for inflation) in any one
year.'' The current threshold after adjustment for inflation is $148
million, using the most current (2016) Implicit Price Deflator for the
Gross Domestic Product. This interim final rule would not result in an
expenditure by industry in any year that meets or exceeds this amount.
This interim final rule extends the compliance date to May 7, 2018,
for the final rule requiring disclosure of certain nutrition
information for standard menu items in certain restaurants and similar
retail food establishments. The principal benefit of this interim final
rule will be the reduction in costs to covered establishments
associated with extending the compliance date by one year. The total
annualized benefit (i.e., cost savings) of this interim final rule,
using a 3-percent discount rate over 20 years, would be from $2 to $6
million; with a 7-percent discount rate, the annualized benefit would
be $3 to $8 million. The principal cost of this interim final rule will
be the reduction in benefits to consumers associated with extending the
compliance date by one year. The total annualized cost (i.e., foregone
benefits) of this interim final rule, using a 3-percent discount rate
over 20 years, would be from $5 to $15 million; with a 7-percent
discount rate, the annualized cost would be $6 to $19 million.
Extending the compliance date of the ``Food Labeling: Nutrition
Labeling of Standard Menu Items in Restaurants and Similar Retail Food
Establishments'' final rule by one year reduces the annualized net
benefits (discounted at 3 percent) approximately 1 percent, from $506
million to $501 million. While average annualized net benefits decrease
by $5 million, they are still positive. We recognize that there may be
additional costs and benefits to both consumers and covered
establishments that we do not have the data to quantify here. We are
presenting the estimated benefits and costs of the menu labeling final
rule, which takes effect according to the dates in this interim final
rule. These quantitative estimates reflect an assumed baseline in which
the menu labeling regulation eventually goes fully into effect. If
statutory or other changes that are separate from FDA rulemaking were
to impact full implementation, the quantitative benefits estimates
would be lower and the quantitative cost estimates higher than shown
here. We invite comment on both this Regulatory Impact Analysis and the
Regulatory Impact Analysis for the December 2014 final rule.
The full analysis of economic impacts is available in the docket
for this interim final rule (Ref. 1) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
IV. Paperwork Reduction Act
This interim final rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 is not required.
V. Analysis of Environmental Impact
We have determined under 21 CFR 25.30(k) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VI. Reference
The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically
[[Page 20829]]
at https://www.regulations.gov. FDA has verified the Web site
addresses, as of the date this document publishes in the Federal
Register, but Web sites are subject to change over time.
1. FDA, interim economic impact analysis for ``Food Labeling;
Nutrition Labeling of Standard Menu Items in Restaurants and Similar
Retail Food Establishments; Extension of Compliance Date; Request
for Comment,'' April 2017. Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.
Dated: May 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09029 Filed 5-1-17; 4:15 pm]
BILLING CODE 4164-01-P